Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to determine the safety and tolerability of a single microinjection of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who have non-infectious uveitis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clearside Biomedical, Inc.
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• diagnosis of non-infectious intermediate, posterior or pan-uveitis

Exclusion Criteria:

• any ocular trauma within the past 6 months in the study eye

• any injection of intraocular corticosteroids or steroid implant or the Ozurdex® implant in the 6 months prior to the study treatment, or any prior use of Retisert™ in the study eye

• any uncontrolled systemic disease that would preclude participation in the study or put the subject at risk due to study treatment or procedures

• have a known HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated

• are monocular

• have ocular hypertension

• history of any intraocular surgery in the study eye

• presence of an anterior staphyloma in the study eye